BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® ASPARTATE AMINOTRANSFERASE PYRIDOXAL-5'-PHOSPHASE (AST) REAGENT

    MDR report key: 2152795 · Received July 7, 2011

    Report

    Report Number
    2050012-2011-02916
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 9, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    CIT
    PMA / PMN Number
    K952427
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAP ON THE REAGENT CARTRIDGE WAS INCORRECTLY SCREWED. THE CUSTOMER REQUESTED A REPLACEMENT. THE REAGENT KIT WAS REPLACED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) IN REGARDS TO A LEAK FROM A PACK OF SYNCHRON ASPARTATE AMINOTRANSFERASE PYRIDOXAL-5'-PHOSPHASE (AST) REAGENT CARTRIDGES. THERE WAS NO EXPOSURE TO UNCOVERED WOUNDS OR MUCOUS MEMBRANES. NO INJURY WAS REPORTED, AND MEDICAL ATTENTION WAS NOT SOUGHT. MSDS WAS REVIEWED AND THE CUSTOMER HAS EXPOSURE CONTROL PLAN IN THE FACILITY. THERE WAS NO EFFECT TO PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® ASPARTATE AMINOTRANSFERASE PYRIDOXAL-5'-PHOSPHASE (AST) REAGENT ASPARTATE AMINOTRANSFERASE PYRIDOXAL-5'-PHOSPHASE REAGENT CIT BECKMAN COULTER, INC. M101633

    Patients

    Seq Age Sex Outcome Treatment
    1